When does API production start? EMA says clarification needed

Starting debate: EMA says rules on API materials need clarification

23-Oct-2014 - Drugmakers’ clashes with regulators over the suitability of API starting materials suggest ICH Q11 is open to interpretation and that clarification is needed according to the EMA.

GSK is looking to save £1bn a year over the next three years

GSK £1bn savings plan to hit manufacture towards 2017, but UK likely immune

23-Oct-2014 - GlaxoSmithKline plans to cut manufacturing, sales and R&D as part of a three year plan to save £1bn ($1.6bn) annually. 

EMA launches rolling Ebola vaccine review plan

EMA launches rolling review process for Ebola vaccine makers

23-Oct-2014 - Ebola vaccine developers can seek scientific guidance and approval through a rolling assessment system established by EMA to accelerate the process review.    

Actavis continues to chop down Forest network post $28bn acquisition

Actavis takes axe to Forest again, with New York jobs to go

23-Oct-2014 - Almost 100 jobs at a commercial packaging facility in New York are set to go as part of Actavis’s continued integration of Forest Laboratories.

European Parliament in Strasbourg, France

Juncked: Plan to move EMA from DG Health to DG Enterprise is abandoned

22-Oct-2014 - DG Health will keep responsibility for the EMA according to European Commission President-elect Jean-Claude Juncker, who confirmed plans to hand the agency to DG Enterprise have been abandoned.

Vaxart's tech platform could develop oral vaccines for viruses including influenza and Ebola

Oral influenza vaccine one step closer, says Vaxart

22-Oct-2014 - A seasonal flu vaccine taken in the form of an oral solid dose has been found comparable to currently available jabs, according to data presented by developer Vaxart.

WHO headquarters in Geneva, Switzerland

Global TB drug development efforts underfunded says WHO

22-Oct-2014 - Janssen-Cilag’s bedaquiline and Otsuka’s delamanid notwithstanding, the drug industry is not spending enough on the development of tuberculosis medicines according to the WHO.

Francis Collins' comments provoked a backlash

NIH: without budget cuts, we’d have Ebola vaccine

22-Oct-2014 - The head of the US National Institutes of Health has said the organisation would have developed a finished Ebola vaccine by now if its funding had not been slashed over the last decade.

EGA wants general chapters for biotherapeutics

Biotherapeutics need general chapters not individual Ph. Eur. monographs says EGA

21-Oct-2014 - Generic drugmakers want biotherapeutic products to have general recommendations in the European Pharmacopoeia rather than individual monographs.

Some drugmakers patent their patient screening tests

The key to market exclusivity? Forget molecules, patent your tests

21-Oct-2014 - Makers of branded drugs are finding ways to extend their marketing authorisation by patenting not only molecules, but patient screening methods and ways of proving bioequivalence.

Doctors ask for quick-dissolve meds to stop in-patient cheating

Doctors ask for quick-dissolve meds to stop in-patient cheating

21-Oct-2014 - Patients receiving court-ordered treatment can be stopped from secretly spitting out their medicines by formulations which dissolve quickly in the mouth.

The Brazilian Wandering Spider may be deadly but its venom could help treat erectile dysfunction

Deadly spider found in UK shopping could provide alternative to Viagra

21-Oct-2014 - Venom from a Brazilian Wandering Spider that ‘wandered’ into a UK household’s shopping basket could treat erectile dysfunction, according to scientists, in one example of drug ingredients being sourced from nature.

New super office will combine a number of different facets.

FDA to combine all of its quality ops under a new ‘super’ office

21-Oct-2014 - By early next year the US FDA is set to launch a new “super” office known as OPQ (Office of Pharmaceutical Quality), which will better align the review, inspection, and research of drugs.

Job changes: Sanofi, AstraZeneca, Novo Nordisk

Job changes: Sanofi, AstraZeneca, Novo Nordisk

20-Oct-2014 - Sanofi has hired an ex-AstraZeneca president as its General Manager for the UK and Ireland.Tarja Stenvall was previously Country President for AstraZeneca Belgium and Luxembourg,...

API hubs expected to emerge in "second wave" countries says RNCOS CEO

Quality probs and rising wages will see new API hubs replace China and India says analyst

20-Oct-2014 - Analysts predicting a second wave of global API hubs say it will be hard for manufacturers in Latin America, Ukraine and Taiwan to avoid the pitfalls that stymied former high growth sectors in Asia.

Health Canada will allow import of 42 'critical' drugs depending on independent quality tests

Canada issues licenses for critical drugs hit by Apotex/IPCA import alert

20-Oct-2014 - Over forty “necessary products” made at Apotex and IPCA facilities hit with an import alert can be sold in Canada after regulators took steps to prevent shortages.

Eli Lilly plans to close and sell one its Guayama, Puerto Rico plant

Eli Lilly to sell PR plant due to patent expirations and shifting portfolio

20-Oct-2014 - Eli Lilly is set to close one of its Puerto Rican facilities as patent expirations and a shifting portfolio reduce its need for capacity.

AbbVie-Shire megamerger unlikely to happen following U-turn in the boardroom

AbbVie leaves $50bn Shire deal for dead following US tax rule changes

16-Oct-2014 - AbbVie’s proposed £31bn ($50bn) takeover of Shire is very likely “dead” after the US biopharma's board changed its recommendation and advised shareholders not to back the bid.

PDPs attracting Big Pharma in Brazil says Jose Piccolotto, head of business development at Brazil's largest drugmaker EMS

Big Pharmas and API suppliers eyeing Brazilian Government deals says EMS

16-Oct-2014 - Government contracts guaranteeing market share in Brazil are starting to attract innovators like Roche, Novartis and Sanofi and may see API suppliers get long-term work according to a spokesman for Sao Bernardo do Campo-based drugmaker, EMS.

Nuclear Magnetic Resonance business no more for Agilent

Agilent to close NMR unit with loss of 300 jobs

15-Oct-2014 - Agilent Technologies is to exit its Nuclear Magnetic Resonance (NMR) business because it has not met growth and profit targets.